# K092655: C. Albicans Pna Fish

- Pathway: 510(k) (Traditional)
- Applicant: Advandx, Inc.
- Decided: Jan 19, 2010 after 144 days
- Product code: NZS (Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
C. albicans PNA FISH is a flucrescence qualitative nucleic.acid hybridization.assay intended for identification of Candida albicans on smears made from yeast positive blood cultures. Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. C. albicans PNA FISH Is indicated for use as an aid in the dlagnosis of C. albicans fungemia.

Source page: https://510kreport.com/device/K092655
Methodology: https://510kreport.com/methodology